Olostar (rosuvastatin/olmesartan medoxomil) / Daewoong Pharma, Daiichi Sankyo - LARVOL DELTA

Study to Evaluate the Effect of Improving Systolic BP and LDL-C Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab (clinicaltrials.gov) - P=N/A | N=2845 | Active, not recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD. | Trial completion date: Jun 2025 ➔ Dec 2025

Trial completion date • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Elevated Risk of Life Threatening Metabolic Acidosis with Combined Metformin and SGLT2 Inhibitor Therapy in the Elderly (ENDO 2025) - "Her home medications included Dapagliflozin 5 mg (started 6 months ago), Metformin XR 500 mg BID (started 8 years ago), Amlodipine, Atenolol, Hydrochlorothiazide, Olmesartan, and Rosuvastatin. Although it is often challenging to identify the exact cause of lactic acidosis, her clinical picture raised suspicion of metformin-induced lactic acidosis due to the initial failure to respond to fluid resuscitation and pressors, followed by improvement after CRRT, and a negative work-up for infection and other causes.There is a similar case presenting severe euglycemic ketoacidosis and lactic acidosis in a diabetic patient on chronic Dapagliflozin and Metformin therapy, which was triggered by poor oral intake and dehydration, ultimately requiring dialysis. Our case underscores the caution needed when using a combination of metformin and SGLT-2 inhibitors, especially in elderly T2D patients with decreased"

Clinical • Alzheimer's Disease • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Dementia • Diabetes • Diabetic Nephropathy • Hypotension • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Elevated Risk of Life-Threatening Metabolic Acidosis with Combined Metformin and SGLT2 Inhibitor Therapy in the Elderly (ESPE-ESE 2025) - "Her home medications included Dapagliflozin 5 mg (started 6 months ago), Metformin XR 500 mg BID (started 8 years ago), Amlodipine, Atenolol, Hydrochlorothiazide, Olmesartan, and Rosuvastatin. Although it is often challenging to identify the exact cause of lactic acidosis, her clinical picture raised suspicion of metformin-induced lactic acidosis due to the initial failure to respond to fluid resuscitation and pressors, followed by improvement after CRRT, and a negative work-up for infection and other causes. 3There is a similar case presenting severe euglycemic ketoacidosis and lactic acidosis in a diabetic patient on chronic Dapagliflozin and Metformin therapy, which was triggered by poor oral intake and dehydration, ultimately requiring dialysis. Our case underscores the caution needed when using a combination of metformin and SGLT-2 inhibitors, especially in elderly T2D patients with decreased GFR."

Clinical • Alzheimer's Disease • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Dementia • Diabetes • Diabetic Nephropathy • Hypotension • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Study to Evaluate the Effect of Improving Systolic BP and LDL-C Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab (clinicaltrials.gov) - P=N/A | N=2845 | Active, not recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD. | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2024 ➔ May 2025 | Trial primary completion date: Apr 2024 ➔ Jan 2025

Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Study to Evaluate the Effect of Improving Systolic BP and LDL-C Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab (clinicaltrials.gov) - P=N/A | N=3000 | Recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD. | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2024 ➔ Oct 2024 | Trial primary completion date: Oct 2023 ➔ Apr 2024

Enrollment open • Trial completion date • Trial primary completion date • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Observational Study to Evaluate the Effect of Improving Systolic BP and LDL-C Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab (clinicaltrials.gov) - P=N/A | N=3000 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

New trial • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Improvement of Endothelial Dysfunction and Inflammation in Ankylosing Spondylitis: IMPROVE-AS study (EULAR 2022) - "Olmesartan and rosuvastatin improve endothelial dysfunction and vascular inflammation and QoL in AS patients. Olmesartan and Rosuvastatin lower the proinflammatory cytokines, especially TNF-α, that upregulate eNOS and downregulates the production of adhesion molecules, CRP and nitric oxide which, in turn, improves endothelial dysfunction. Both drugs also decrease nitrite concentration and improve the EPC population in AS patients."

Ankylosing Spondylitis • Atherosclerosis • Cardiovascular • Dyslipidemia • Immune Modulation • Immunology • Inflammation • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CD133 • CD34 • ICAM1 • IL6 • NOS3 • TNFA • VCAM1

Candidate drugs for preventive treatment of unruptured intracranial aneurysms: A cross-sectional study. (PubMed, PLoS One) - "The present analysis suggests that several types of statins, calcium channel blockers, and ARBs are candidate drugs for preventive treatment of unruptured IAs."

Journal • Observational data • Cardiovascular • Immunology

Effect of FIXed-dose combination of ARb and statin on adherence and risk factor control: The randomized FIXAR study. (PubMed, Cardiol J) - "Patients' adherence was excellent and similar in the groups, whereas the reduction in the LDL-C level was greater in the FDC group. We provide comprehensive information on the adherence and efficacy of an FDC compared to the usual regimen in Korean patients with high cardiovascular risk."

Clinical • Journal • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Clinical Outcomes of Olmesartan/Rosuvastatin Combination Therapy in Acute Coronary Syndrome Patients With Essential Hypertension. (PubMed, Am J Ther) - No abstract available

Clinical • Clinical data • Combination therapy • Journal • Acute Coronary Syndrome • Cardiovascular • Hypertension

[VIRTUAL] Post-operative toxic reaction reversed through pharmacogenetics screening: a case report (ESHG 2020) - "Taking into account these results, valsartan was replaced by olmesartan and atorvastatin by rosuvastatin; in both cases the alternative drug belonged to the same class but the key pharmacogene is SLCO1B1 (normal function, *1A/*1B). After only two days the patient felt "as good as before"; within 4 weeks, liver transaminases sank to quasi-normal values.The complex genetic findings suggest several interactions initially caused by post-operative drugs but knowing the predicted activity of key pharmacogenes facilitates selection of the best treatment leading, in this patient, to reversing the toxic reaction she was experiencing."

Biomarker • Clinical • Cardiovascular • Coronary Artery Disease • Heart Failure • Pain • CYP2C9 • CYP2D6 • CYP3A5 • NAT2 • UGT1A1

Synergistic protective effects of a statin and an angiotensin receptor blocker for initiation and progression of atherosclerosis. (PubMed, PLoS One) - "Combination treatment with a statin and an ARB produced synergistic protective effects for atherosclerosis initiation and progression, which may be attributed to modulation of macrophage characteristics in the early period of atherosclerosis."

Journal

Pharmacokinetic comparison of a fixed-dose combination versus concomitant administration of amlodipine, olmesartan, and rosuvastatin in healthy adult subjects. (PubMed, Drug Des Devel Ther) - " The 90% CI of the primary PK parameters were within the acceptance bioequivalence criteria, which is ln (0.8) and ln (1.25). These results indicate that the FDC formulation and co-administration of amlodipine, olmesartan and rosuvastatin are pharmacokinetically bioequivalent and have similar safety profiles."

Clinical • Journal • PK/PD data

IMPROVEMENT OF ENDOTHELIAL DYSFUNCTION AND INFLAMMATION IN PSORIATIC ARTHRITIS: IMPROVE – PSA STUDY (EULAR 2019) - "Olmesartan and rosuvastatin improve endothelial dysfunction, inflammation, CV risk and quality of life in PsA patients. Olmesartan and Rosuvastatin lower the proinflammatory cytokines, especially TNF-α, that down regulates production of CRP, adhesion molecules and nitric oxide which in turn improves endothelial dysfunction. Both drugs also decrease nitrite concentration and improve the EPC population in PsA patients."